1. Field of the Invention
This invention relates to an apparatus and method for introducing a splittable catheter and thereafter splitting the catheter with a winged adapter. More particularly, the introducer herein is for one handed introduction of a splittable catheter and thereafter initiating the splitting of the catheter with the one hand pressing the wings of the adapter together.
2. Background Description
The invention described in this application is related to the subject matter in U.S. application Ser. No. 838,739 filed Mar. 11, 1986, now U.S. Pat. No. 4,661,300, issued Apr. 28, 1987 and co-pending U.S. application Ser. No. 011,783 filed Feb. 6, 1987 now U.S. Pat. No. 4,776,846 and co-pending U.S. application Ser. No. 227,040, filed Aug. 1, 1988, now U.S. Pat. No. 4,952,359, and U.S. application Ser. No. 191,523, filed May 9, 1988, now abandoned.
Splittable introducer catheters are used in inserting long-term catheter arrangements into patients. That is, when attempting to insert long-line catheters into the human body the procedure includes making the venipuncture with a hollow needle that carries coaxially thereover a splittable placement or introducer catheter of the kind to which this invention is directed. Once the vein has been penetrated, and blood is visible in the flashback chamber of such an assembly, the needle and flashback chamber are removed leaving the placement catheter through the site of the puncture and into the lumen of the vessel.
Thereafter, a long-line catheter or guidewire is threaded through the placed catheter, and thereafter the catheter is removed from the vein by axial sliding movement along the guidewire, for example, leaving the guidewire or long-line catheter in place. The removed placement or introducer catheter is designed to split longitudinally from its coaxial position over the guidewire or long-line catheter, so that it may be readily removed without any difficulty or irritation to the patient.
With respect to the above-noted U.S. Pat. No. 4,776,846 that patent teaches an invention for producing a splittable introducer or placement catheter with diametrically opposed longitudinally extending grooves positioned in the outer surface of the placement catheter. These grooves facilitate the stripping of the introducer catheter once the guidewire and long-line catheter are in place. A difficult part of handling catheters of the kind discussed herein is the entry when carried over a needle and through the skin of a patient and any trauma or other undesirable circumstances caused thereby. Specifically the placement of the splittable catheter in the vessel requires skill, technique and an easily controlled introducer.
U.S. Pat. No. 4,377,165 shows a needle with longitudinal fracture lines that is split by pulling apart a pair of finger-wings with two hands. The use of a splittable needle to introduce a catheter or guide wire is not favored because the rigid needle tends to irritate the lining of the vessel lumen. A non-rigid introducer reduces the risk of tissue damage and/or damage to the indwelling device as it is inserted and adjusted, and prevents patient injury or death from a catheter severed by a rigid introducer. U.S. Pat. No. Re. 31,855 shows a splittable catheter of linearly oriented material that tears readily in the longitudinal direction propagated by pulling tabs attached to opposite sides of the catheter. U.S. Pat. No. 4,581,025 shows several different embodiments of the preceding reissue patent. U.S. Pat. No. 4,412,832 has a peelable catheter with score lines and a sliding suture sleeve to prevent premature splitting. U.S. Pat. No. 4,411,654 has an anti-rotation feature and fingerloops to peel catheter. Braun, a West German company, markets a product with a splittable catheter having a longitudinally tearing tube initiated by pulling apart two tabs which break the catheter adapter in half.
The adapter for the splittable catheter has to include something to tear the splittable catheter apart and still be easy to handle during the insertion procedure. A single handed introduction is preferred because the other hand is free to hold the patient's arm, for example. Therefore an adapter which has a needle that is held within the catheter is preferred. U.S. Pat. No. 4,362,156 shows opposing latches attached to a needle hub which lock onto a catheter adapter. U.S. Pat. No. 4,192,305 shows a pawl type latch holding a catheter to a needle hub.